GI Drugs Cmte. To Weigh Retreatment Study Design For Salix's Xifaxan In Irritable Bowel
This article was originally published in The Pink Sheet Daily
On Nov. 16, FDA's outside advisors will discuss the design of clinical trials to evaluate the safety, efficacy and durability of response with repeat treatment cycles of rifaximin for diarrhea-predominant IBS.
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FDA’s Gastrointestinal Drugs Advisory Committee Nov. 16 will review a trial design for evaluating the safety and efficacy of retreatment for the chronic condition with Silax’s antibiotic Xifaxan.
Although privately held Oceana’s two products – Solesta and Deflux – are regulated by FDA as Class III medical devices, Salix intends to market them with existing sales forces.
Serotonin receptor 4 agonists for use in constipation have been in limbo due to potential for CV risk; FDA is seeking recommendations about safety studies for the class from an advisory committee.